Effects of a Combined Transcranial Magnetic Stimulation (TMS) and Cognitive Training in Alzheimer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Neuronix Ltd
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01504958
First received: September 29, 2011
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

This study looks at the potential benefits of combining cognitive training (mental exercises) together with transcranial magnetic stimulation (also known as TMS) to see if this can make a difference in the condition of people with Alzheimer's disease by improving their disease and the cognitive decline that goes along with it.


Condition Intervention Phase
Alzheimer's Disease
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Behavioral: NICE Cognitive Training
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a Combined TMS and Cognitive Training in Alzheimer Patients: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Alzheimer's Disease Assessment Scale (ADAS-Cog) [ Time Frame: Pre treatment; post treatment; 1, 2, and 3 months post treatment ] [ Designated as safety issue: No ]
    Assessment to measure the severity of all of the most important symptoms of Alzheimer's disease: loss of memory, language, praxis, and attention.


Secondary Outcome Measures:
  • Weschler Test of Adult Reading (WTAR) [ Time Frame: Pre-treatment, post treatment ] [ Designated as safety issue: No ]
    Brief test to estimate level of intelligence

  • Clinical Global Impression Change (CGIC) [ Time Frame: Pre-treatment, post treatment ] [ Designated as safety issue: No ]
    A three-item scale used to assess treatment response in psychiatric patients. They are severity of illness, global improvement, and efficacy index.

  • Modified Rey Auditory Verbal Learning Test (RAVLT) [ Time Frame: Pre-treatment; post treatment; 1, 2, and 3 months post treatment ] [ Designated as safety issue: No ]
    Assess immediate and delayed memory function.

  • NACC's UDS Neuropsychological Battery Test [ Time Frame: Pre-treatment, post treatment ] [ Designated as safety issue: No ]

    Consists of:

    • Logical memory (immediate and delayed)
    • Digit span forward
    • Digit span backward
    • Category fluency (animals and vegetables)
    • WAIS-R Digit symbol
    • Boston naming test


Estimated Enrollment: 20
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active rTMS
High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).

Sham participants will receive the same study procedures as patients receiving active rTMS.

Other Names:
  • Transcranial Magnetic Stimulation
  • Noninvasive Brain Stimulation
Behavioral: NICE Cognitive Training

12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).

A particular cognitive exercise will start 200msec after the termination of each TMS train.

Sham participants receive real cognitive training that follows the same procedures as the active group.

Other Names:
  • Cognitive Training
  • Mental exercises
Sham Comparator: Sham rTMS
High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).

Sham participants will receive the same study procedures as patients receiving active rTMS.

Other Names:
  • Transcranial Magnetic Stimulation
  • Noninvasive Brain Stimulation
Behavioral: NICE Cognitive Training

12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).

A particular cognitive exercise will start 200msec after the termination of each TMS train.

Sham participants receive real cognitive training that follows the same procedures as the active group.

Other Names:
  • Cognitive Training
  • Mental exercises

Detailed Description:

This study takes place in Boston, Massachusetts and Beth Israel Deaconess Medical Center. The treatment portion of the study requires patients to visit the BIDMC daily, Monday through Friday, for 6 weeks. All participants will receive real cognitive training, but half of our participants will receive active TMS treatment and half will receive a placebo TMS treatment. However, those receiving the placebo treatment will be offered the real treatment upon the completion of the study. This study goes up to approximately 4.5 months.

TMS is a noninvasive way of stimulating the brain, which is not painful and does not involve any needles or any form of surgery. It acts by delivering a magnetic stimulation to a particular region of your brain and that, coupled with the cognitive training, is what is being looked at in this study. The investigators are examining if this combination of TMS and cognitive training will improve your memory function and other mental functions such as language, orientation, and thinking or judgment.

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female age 55-90
  • Diagnosed with mild to moderate AD according to DSM-IV criteria
  • Diagnosis of dementia of the Alzheimer's type according to the criteria established by the NINCDS-ADRDA
  • Normal or corrected normal ability to see and hear
  • Primary language is English

Exclusion Criteria:

  • IQ below 85
  • Any major structural abnormalities on MRI (eg. Infarction, intracerebral malformation)
  • Any symptoms of disease or abnormalities sufficient to cause memory impairment other than AD (eg. Normal pressure hydrocephalus, progressive supranuclear palsy)
  • Any functional psychiatric disorder (eg. Schizophrenia)
  • Chronic uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (eg. Cardiac malformation)
  • History of seizures, diagnosis of epilepsy
  • Metal implants excluding dental fillings or any of the following medical devices: pacemaker, implanted medication pump, vagal nerve stimulator, deep brain stimulator, TENS unit (unless removed completely for this study), cerebral spinal fluid shunt
  • Recent withdrawal from the following drugs: alcohol, barbiturates, benzodiazepines, meprobamate, chloral hydrate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01504958

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Neuronix Ltd
Investigators
Principal Investigator: Alvaro Pascual-Leone, M.D., Ph.D. Beth Israel Deaconess Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01504958     History of Changes
Other Study ID Numbers: 2010P-000325
Study First Received: September 29, 2011
Last Updated: May 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
Alzheimer's disease
Cognitive Training
Transcranial Magnetic Stimulation

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 15, 2014